Spontaneous Breathing Trial, Spontaneous Breathing Trial in ICU
Conditions
Keywords
spontaneous breathing trials, Pet-robotic intervention, anxiety, Robot assisted intervention
Brief summary
This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.
Detailed description
This study aims to investigate the effectiveness of pet robotic intervention during spontaneous breathing trials in adult patients admitted to medical intensive care units. The study explores whether this intervention can alleviate patients' anxiety during the weaning process, as well as enhance successful spontaneous breathing trials and facilitate further extubation.
Interventions
BEHAVIORALRobotic pet (PARO) companionship
The intervention is composed of the following components: Duration: Robotic pet companionship lasting 30-120 minutes, depending on clinical goals during each spontaneous breathing trial (SBT). Preparation and interaction: PARO is introduced 30 minutes before each SBT to establish emotional connection. Study staff will briefly introduce its interactive features, including responding to stroking, gentle tapping, head movements, and eye blinking. Participants may interact freely with PARO during the intervention. Assessment: Outcome measurements are conducted during the intervention. If extubated successfully, a semi-structured interview is conducted three days later. Early termination: The intervention is stopped if the participant becomes clinically unsuitable for further SBTs or experiences a serious adverse event (e.g., device dislodgement). Additional information: After each SBT, PARO is sterilized and stored in a sealed container in the patient's room.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older with clear consciousness. * Mechanical ventilation for more than 72 hours. * Previously failed the first spontaneous breathing trial and is clinically ready to undergo a second spontaneous breathing trial.
Exclusion criteria
* Multidrug-resistant organism infection. * Requiring airborne infection isolation precautions (e.g., COVID-19). * Immunodeficiency (absolute neutrophil count \< 500 cells/mL). * Richmond Agitation-Sedation Scale (RASS) less than -1. * Patient with a tracheostomy. * Subjects with implanted cardiac devices (e.g., permanent pacemaker, implantable cardioverter defibrillators) * Known allergy to the fur of the robotic pet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral responses | Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 until extubation, intensive care unit discharge, or early termination. | Behavioral responses will be assessed using the Motor Activity Assessment Score (MAAS). Data will be analyzed as both continuous and categorical variables. Continuous variable: mean MAAS score (range 0-6). Categorical variables: Sedated (MAAS 0-2); Cooperative (MAAS = 3); Agitated (MAAS 4-6). |
| Subjective Psychological response | Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety). |
| Objective Psychological Response | During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Crying or anger for more than five minutes (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Signs of respiratory distress - oxygen saturation | Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Average peripheral oxygen saturation measured in percent. |
| Spontaneous breathing trial outcome | After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Completion of spontaneous breathing trial (Yes/No). |
| Duration of spontaneous breathing trial | After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Total duration of completed spontaneous breathing trial measured in minutes. |
| Signs of respiratory distress - heart rate | Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Average heart rate measured in beats per minute (bpm). |
| Extubation within 24 hours | Within 24 hours from Day 1 of measurement. | Extubation is defined as removal of the endotracheal tube after the physician's evaluation and confirmation of readiness. Success is defined as removal of the tube within 24 hours and is measured as yes/no. |
| Experience of using robotic pet | 3 days after extubation. | A semi-structured interview will be conducted with participants in the experimental arm. The interview will include the following four domains: 1. Experiences with the spontaneous breathing trials. 2. Experiences with robotic pet companionship. 3. Perceived helpfulness of the robotic pet in alleviating anxiety. 4. Suggestions for future use of the robotic pet. |
| Adverse events | From Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | All adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), as defined by Good Clinical Practice (GCP), will be recorded. |
| Signs of respiratory distress - blood pressure | Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Average blood pressure measured in millimeters of mercury (mmHg). |
| Signs of respiratory distress - respiratory rate | Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination. | Average respiratory rate measured in breaths per minute. |
Countries
Taiwan
Outcome results
None listed